uniQure Accused of Misleading Investors Over FDA Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2h ago
0mins
Should l Buy QURE?
Source: Businesswire
- Class Action Filed: Robbins LLP has initiated a class action on behalf of investors who purchased uniQure N.V. (NASDAQ: QURE) shares between September 24, 2025, and October 31, 2025, alleging misleading statements regarding the likelihood of FDA approval, potentially leading to significant investor losses.
- FDA Feedback Impact: On November 3, 2025, uniQure disclosed that the FDA indicated its AMT-130 clinical trial data may not provide adequate primary evidence for BLA submission, resulting in a stock price drop of $33.40, or over 49%, from $67.69 to $34.29.
- Study Design Issues: The complaint highlights that uniQure failed to disclose that the design of its pivotal study was not fully approved by the FDA, and downplayed the need for additional studies to support its BLA submission, further damaging the company's credibility.
- Investor Rights Protection: Investors can apply to be lead plaintiffs in the class action by April 7, 2026, with Robbins LLP offering representation on a contingency fee basis, aiming to help investors recover losses and improve corporate governance practices.
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Analyst Views on QURE
Wall Street analysts forecast QURE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for QURE is 49.88 USD with a low forecast of 33.00 USD and a high forecast of 70.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
10 Analyst Rating
8 Buy
2 Hold
0 Sell
Strong Buy
Current: 26.050
Low
33.00
Averages
49.88
High
70.00
Current: 26.050
Low
33.00
Averages
49.88
High
70.00
About QURE
Uniqure NV is a company based in the Netherlands specialized in gene therapy. It seeks to develop one-time administered treatments with potentially curative results for patients suffering from genetic and other devastating diseases. It develops, both internally and through partnerships, a pipeline of gene therapies. It produces adeno-associated virus based, or AAV-based, gene therapies in its own facilities with a proprietary, commercial-scale, current good manufacturing practices, compliant, manufacturing process. AMT-061, the Company’s lead product candidate for patients with hemophilia B, is going through a dosing phase of a pivotal study. AMT-130, the product candidate for patients with Huntington’s disease is in Phase I/II clinical study.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
uniQure Accused of Misleading Investors Over FDA Approval
- Class Action Filed: Robbins LLP has initiated a class action on behalf of investors who purchased uniQure N.V. (NASDAQ: QURE) shares between September 24, 2025, and October 31, 2025, alleging misleading statements regarding the likelihood of FDA approval, potentially leading to significant investor losses.
- FDA Feedback Impact: On November 3, 2025, uniQure disclosed that the FDA indicated its AMT-130 clinical trial data may not provide adequate primary evidence for BLA submission, resulting in a stock price drop of $33.40, or over 49%, from $67.69 to $34.29.
- Study Design Issues: The complaint highlights that uniQure failed to disclose that the design of its pivotal study was not fully approved by the FDA, and downplayed the need for additional studies to support its BLA submission, further damaging the company's credibility.
- Investor Rights Protection: Investors can apply to be lead plaintiffs in the class action by April 7, 2026, with Robbins LLP offering representation on a contingency fee basis, aiming to help investors recover losses and improve corporate governance practices.
See More
uniQure Faces Class Action Lawsuit
- Class Action Initiated: Bragar Eagel & Squire has filed a class action lawsuit against uniQure in the Southern District of New York on behalf of investors who purchased shares between September 24, 2025, and October 31, 2025, indicating significant legal risks for the company.
- False Statement Allegations: The complaint alleges that uniQure made materially false and misleading statements during the class period and failed to disclose adverse facts about its business and operations, potentially leading to investor losses.
- FDA Approval Issues: The lawsuit highlights that the design of uniQure's pivotal study was not fully approved by the FDA, and the company may need to delay its Biologics License Application (BLA) timeline to conduct additional studies, impacting its market outlook.
- Investor Rights Protection: Investors must apply by April 13, 2026, to be appointed as lead plaintiff in the lawsuit, with Bragar Eagel & Squire offering no-cost legal consultations aimed at protecting investor rights.
See More
uniQure Faces Securities Fraud Class Action Lawsuit
- Lawsuit Background: Kessler Topaz Meltzer & Check, LLP has filed a securities fraud class action against uniQure N.V. on behalf of investors who purchased shares between September 24 and October 31, 2025, indicating a significant loss of investor confidence in the company's performance.
- Stock Price Volatility: On September 24, 2025, uniQure's stock surged from $13.66 to $47.50, a nearly 250% increase, but plummeted over 49% to $34.29 by November 3, 2025, following the FDA's shift in stance regarding the BLA submission, reflecting extreme market anxiety about the company's prospects.
- Clinical Trial Issues: The FDA did not fully approve the design of uniQure's Pivotal Study for the AMT-130 drug, necessitating a delay in the BLA submission timeline, which severely undermined investor confidence and highlighted significant flaws in the company's clinical trial design.
- Investor Rights: Investors may seek to be appointed as lead plaintiffs in the class action by April 13, 2026, representing all affected investors, indicating that this case could have profound implications for uniQure's reputation and future financing capabilities.
See More
uniQure Updates AMT-191 Clinical Data for Fabry Disease
- Clinical Trial Progress: uniQure has updated preliminary safety and exploratory efficacy data from its Phase 1/2a trial of AMT-191 involving 11 patients, with all showing significant increases in α-galactosidase A activity across three dosing cohorts, indicating the gene therapy's potential in treating Fabry disease.
- Dose-Dependent Response: α-galactosidase A activity increased to 0.34-82.2 times, 1.6-312.52 times, and 27.7-223.7 times the normal level across the different dose groups, demonstrating a dose-dependent response, with these increases remaining stable over follow-up periods of up to more than a year, indicating the therapy's durability.
- Safety Analysis: No serious adverse events were observed at the 4×10^13 gc/kg and 2×10^13 gc/kg doses, although two patients at the 4×10^13 gc/kg dose experienced asymptomatic Grade 3 liver enzyme elevations, confirmed as dose-limiting toxicity, showcasing the manageable safety profile of the therapy.
- Market Reaction: Following the announcement, uniQure's shares rose by 6.10% to $26.01, reflecting positive market sentiment towards the clinical data of AMT-191 and potentially boosting investor confidence in the company's future prospects.
See More
uniQure Updates AMT-191 Clinical Data for Fabry Disease
- Efficacy Data Update: As of January 8, 2026, all 11 patients in the three dosing cohorts of AMT-191 exhibited significant elevations in α-Gal A activity, with the lowest dose showing increases of 0.34 to 82.2-fold, indicating the therapy's potential in treating Fabry disease.
- Good Tolerability: No serious adverse events related to AMT-191 were observed at the 4x10^13 gc/kg and 2x10^13 gc/kg doses, demonstrating the safety profile of the therapy, although two patients at the 4x10^13 gc/kg dose experienced asymptomatic Grade 3 liver enzyme elevations.
- Patient Treatment Transition: Six out of 11 patients have discontinued enzyme replacement therapy by the data cutoff date, meeting pre-specified criteria, which highlights AMT-191's potential to replace traditional treatments and enhance patient options.
- Ongoing Clinical Trials: The Phase I/IIa clinical trial of AMT-191 is still underway, with uniQure planning to provide further updates in the future to support the therapy's potential as a one-time gene treatment for patients with Fabry disease.
See More
uniQure Faces Investigation Over FDA Data Issues
- Insufficient FDA Data: On November 3, 2025, uniQure revealed that the FDA informed the company that data for its AMT-130 Biologics License Application (BLA) lacked sufficient evidence, leading to uncertainty regarding the timing of the BLA submission, which directly impacts future product launch plans.
- Stock Price Plunge: Following this announcement, uniQure's stock price plummeted over 50%, from $67.69 on October 31, 2025, to $34.29 on November 3, indicating extreme market pessimism regarding the company's prospects.
- Legal Investigation Initiated: Kessler Topaz Meltzer & Check LLP is investigating potential violations of federal securities laws by uniQure, aiming to protect investor rights and pursue possible legal remedies, highlighting concerns over corporate governance and compliance.
- Investor Impact: This incident not only undermines shareholder confidence in uniQure but may also lead to difficulties in future financing, thereby affecting its research and development capabilities and market competitiveness, especially in the capital-intensive gene therapy sector.
See More
uniQure Accused of Misleading Investors Over FDA Approval
- Class Action Filed: Robbins LLP has initiated a class action on behalf of investors who purchased uniQure N.V. (NASDAQ: QURE) shares between September 24, 2025, and October 31, 2025, alleging misleading statements regarding the likelihood of FDA approval, potentially leading to significant investor losses.
- FDA Feedback Impact: On November 3, 2025, uniQure disclosed that the FDA indicated its AMT-130 clinical trial data may not provide adequate primary evidence for BLA submission, resulting in a stock price drop of $33.40, or over 49%, from $67.69 to $34.29.
- Study Design Issues: The complaint highlights that uniQure failed to disclose that the design of its pivotal study was not fully approved by the FDA, and downplayed the need for additional studies to support its BLA submission, further damaging the company's credibility.
- Investor Rights Protection: Investors can apply to be lead plaintiffs in the class action by April 7, 2026, with Robbins LLP offering representation on a contingency fee basis, aiming to help investors recover losses and improve corporate governance practices.
See More
uniQure Faces Class Action Lawsuit
- Class Action Initiated: Bragar Eagel & Squire has filed a class action lawsuit against uniQure in the Southern District of New York on behalf of investors who purchased shares between September 24, 2025, and October 31, 2025, indicating significant legal risks for the company.
- False Statement Allegations: The complaint alleges that uniQure made materially false and misleading statements during the class period and failed to disclose adverse facts about its business and operations, potentially leading to investor losses.
- FDA Approval Issues: The lawsuit highlights that the design of uniQure's pivotal study was not fully approved by the FDA, and the company may need to delay its Biologics License Application (BLA) timeline to conduct additional studies, impacting its market outlook.
- Investor Rights Protection: Investors must apply by April 13, 2026, to be appointed as lead plaintiff in the lawsuit, with Bragar Eagel & Squire offering no-cost legal consultations aimed at protecting investor rights.
See More
uniQure Faces Securities Fraud Class Action Lawsuit
- Lawsuit Background: Kessler Topaz Meltzer & Check, LLP has filed a securities fraud class action against uniQure N.V. on behalf of investors who purchased shares between September 24 and October 31, 2025, indicating a significant loss of investor confidence in the company's performance.
- Stock Price Volatility: On September 24, 2025, uniQure's stock surged from $13.66 to $47.50, a nearly 250% increase, but plummeted over 49% to $34.29 by November 3, 2025, following the FDA's shift in stance regarding the BLA submission, reflecting extreme market anxiety about the company's prospects.
- Clinical Trial Issues: The FDA did not fully approve the design of uniQure's Pivotal Study for the AMT-130 drug, necessitating a delay in the BLA submission timeline, which severely undermined investor confidence and highlighted significant flaws in the company's clinical trial design.
- Investor Rights: Investors may seek to be appointed as lead plaintiffs in the class action by April 13, 2026, representing all affected investors, indicating that this case could have profound implications for uniQure's reputation and future financing capabilities.
See More
uniQure Updates AMT-191 Clinical Data for Fabry Disease
- Clinical Trial Progress: uniQure has updated preliminary safety and exploratory efficacy data from its Phase 1/2a trial of AMT-191 involving 11 patients, with all showing significant increases in α-galactosidase A activity across three dosing cohorts, indicating the gene therapy's potential in treating Fabry disease.
- Dose-Dependent Response: α-galactosidase A activity increased to 0.34-82.2 times, 1.6-312.52 times, and 27.7-223.7 times the normal level across the different dose groups, demonstrating a dose-dependent response, with these increases remaining stable over follow-up periods of up to more than a year, indicating the therapy's durability.
- Safety Analysis: No serious adverse events were observed at the 4×10^13 gc/kg and 2×10^13 gc/kg doses, although two patients at the 4×10^13 gc/kg dose experienced asymptomatic Grade 3 liver enzyme elevations, confirmed as dose-limiting toxicity, showcasing the manageable safety profile of the therapy.
- Market Reaction: Following the announcement, uniQure's shares rose by 6.10% to $26.01, reflecting positive market sentiment towards the clinical data of AMT-191 and potentially boosting investor confidence in the company's future prospects.
See More
uniQure Updates AMT-191 Clinical Data for Fabry Disease
- Efficacy Data Update: As of January 8, 2026, all 11 patients in the three dosing cohorts of AMT-191 exhibited significant elevations in α-Gal A activity, with the lowest dose showing increases of 0.34 to 82.2-fold, indicating the therapy's potential in treating Fabry disease.
- Good Tolerability: No serious adverse events related to AMT-191 were observed at the 4x10^13 gc/kg and 2x10^13 gc/kg doses, demonstrating the safety profile of the therapy, although two patients at the 4x10^13 gc/kg dose experienced asymptomatic Grade 3 liver enzyme elevations.
- Patient Treatment Transition: Six out of 11 patients have discontinued enzyme replacement therapy by the data cutoff date, meeting pre-specified criteria, which highlights AMT-191's potential to replace traditional treatments and enhance patient options.
- Ongoing Clinical Trials: The Phase I/IIa clinical trial of AMT-191 is still underway, with uniQure planning to provide further updates in the future to support the therapy's potential as a one-time gene treatment for patients with Fabry disease.
See More
uniQure Faces Investigation Over FDA Data Issues
- Insufficient FDA Data: On November 3, 2025, uniQure revealed that the FDA informed the company that data for its AMT-130 Biologics License Application (BLA) lacked sufficient evidence, leading to uncertainty regarding the timing of the BLA submission, which directly impacts future product launch plans.
- Stock Price Plunge: Following this announcement, uniQure's stock price plummeted over 50%, from $67.69 on October 31, 2025, to $34.29 on November 3, indicating extreme market pessimism regarding the company's prospects.
- Legal Investigation Initiated: Kessler Topaz Meltzer & Check LLP is investigating potential violations of federal securities laws by uniQure, aiming to protect investor rights and pursue possible legal remedies, highlighting concerns over corporate governance and compliance.
- Investor Impact: This incident not only undermines shareholder confidence in uniQure but may also lead to difficulties in future financing, thereby affecting its research and development capabilities and market competitiveness, especially in the capital-intensive gene therapy sector.
See More
